1. Field of the Invention
This invention relates to medical devices used in controlling urinary incontinence in females. More specifically, this invention relates to devices which are completely inserted into the vagina for controlling the urethro-vesicle angle for regulating the flow of urine through the urethra from the bladder to the urethral opening.
2. Description of the Prior Art
Urinary incontinence in females has long been a serious problem for which no truly acceptable long term solution has been found. In severe cases of urinary incontinence, the female has no control of the excretion of urine from the bladder. This condition requires immediate medical attention and is often cured only by surgical means. However, in most circumstances the patient has some residual control over the urinating function, but cannot prevent the excretion of urine during stress situations such as coughing, sneezing, or physical exercise. At these times, the patient involuntarily releases a spurt of urine from the urethra when any type of pressure is exerted on the bladder. Even a small volume of urine which is allowed to contaminate the genital sections of the female can cause irritation and more importantly an offensive odor. The presence of the offensive odor can cause an antisocial attitude in the patient who fears that other people in the vicinity will take notice of the problem.
One solution to the problem of urinary incontinence is the use of absorbent pads in the genital section adjacent the urethral opening. These pads are genereally regarded as an unacceptable solution due to the limited volume of the urine which can be absorbed by the pads and the high probability of infection and inflammation of the skin exposed to the pad. Catheters may also be inserted into the urethra, but these catheters can cause infections and are generally only used during controlled circumstances, such as when the patient is under constant medical care in a hospital.
Surgical repair of the physical abnormality is also commonly practiced. In one type of operation a Kennedy stitch is used to secure the urethra to the periosteum of the pubic bone, which, if properly accomplished, results in a significant reduction in the urethro-vesicle angle. While this operation may be performed through an incision in the vaginal wall, it is also possible to accomplish the same repairs through an incision in the abdomen. While these surgical techniques are often effective for periods of several years, the urethra may break loose from its ties with the periosteum following extensive activity, thereby causing a recurrence of the urinary incontinence condition. The use of surgical techniques for relieving urinary incontinence is often not practical due to the age, health, or medical history of the patient. It should be noted that these surgical techniques are useful only in treating stress incontinence as opposed to neurogenic incontinence which results form a complete loss of control by the nervous system of the muscles controlling the urinary function.
Other inventors and medical specialists have discovered that by altering the angular relationship between the urethra and the bladder, the urinary incontinence can be regulated. By making the urethro-vesicle angle, which is defined between the urethra and the bladder, more acute, that is reducing the included angle between the urethra and the bladder, urinary incontinence can be significantly reduced.
In U.S. Pat. No. 3,705,575 Edwards discloses an incontinence device comprising of a first member which is adapted to fit within the vagina and which applies pressure to the urethra, and a second member adapted to bear against the external pubic area of the female body. The first and second members are coupled together by a generally U-shaped structure which resiliently urges the first and second members toward each other. As compared with the present invention, the Edwards device is uncomfortable to wear and can easily irritate the tender mucosal tissues adjacent the labia.
Habib in U.S. Pat. No. 3,554,184 discloses an incontinence device which is formed from silicone rubber and which is designed to be inserted into the anterior region of the vagina. A belt worn around the waist of the patient is coupled to the member and thrusts it upwardly against the superior wall of the vagina with a sufficient magnitude to effectively block the flow of urine through the urethra. The Habib device requires the wearing of an uncomfortable belt surrounding the waist of the patient. Also, the use of a device which is only partially contained within the vagina may cause serious irritation of the membranes of the labia.
Bonnar in U.S. Pat. No. 3,646,929 discloses a female incontinence device which comprises a generally flat support adapted for insertion into and retention by the vagina. A flexible diaphragm is coupled to the support and is inflated to expand in an upward direction against the superior wall of the vagina to exert pressure thereupon for applying pressure to block the urethra. As with the other inventions, the Bonnar device requires that a part of the apparatus must extend from the vagina, thereby increasing the probability of irritation to mucosal membranes surrounding the vagina. The inventions disclosed by Kulick in U.S. Pat. No 2,638,093 and Vincent in U.S. Pat. No. 3,080,865 are similar to the prior art patents already discussed.
Sluijter in U.S. Pat. No. 2,649,086 discloses a ring-shaped elastic member for being inserted into the vagina adjacent the opening thereof. The ring includes thereon an outwardly projecting thickened portion which is oriented to press against the superior surface of the vagina adjacent the opening thereof for closing off the "contractor" section of the urethra, that is the area adjacent the sphincter muscles adjacent the urethral opening. Whereas the Sluijter device exerts pressure to block the urethra opening -- which means that the device must be removed from the vagina before the patient urinates -- the present invention elevates a section of the urethra intermediate the bladder and the urethral opening for decreasing the urethro-vesicle angle -- which means that the patient may urinate without removing the device from the vagina. Therefore, while the Sluijter device blocks all urine from flowing through the urethra, the present invention restores the natural geometry of the urethro-vesicle angle to allow the patient to naturally control the flow of urine.